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LM

L. M.

Chimie

Port-au-Prince 19 ans d’expérience

À propos

Specialist in Quality Assurance /Product Quality/Supply Chain

Expériences professionnelles

Sep 2014 — Présent

Senior Quality Assurance Specialist

Management Sciences for Health · ONG

•Ensure that the SCMS project is equipped with the right Quality Assurance system by designing and implementing performance tools such as a strong certified SOP system supported by training of personnel, a robust documentation system comprised of records, forms, work instructions as per PFSCM quality system requirements. •Work with Procurement in advising on products shelf-life, and ensuring certification of products quality prior to processing of shipments in order to minimize expired products within the supply chain. •Ensure adequate storage conditions at the central warehouse and during distribution to the USG partnered sites to guarantee product quality throughout the entire supply chain. •Conduct internal review of the central warehouse, identify gaps and perform root cause analysis, implement preventive and corrective actions as needed. •Investigate and respond to sites concerns relating to drug quality. Carry out product surveillance and oversee all processes related to adverse drug reactions, labeling changes, safety alerts and drug recalls. •Strengthen the QA capacity standards at national levels for control of the commodities by providing support to the DPM/MT in the development of a National Manual of Quality Assurance of Finished Pharmaceutical Products. •Share the SCMS Quality Assurance program with the Government counterparts, and provide technical support to the Ministry of Health in Haiti in designing a Quality Assurance management system for the Unified Supply Chain under the guidance of organizations such as WHO and USAID.
Nov 2013 — Sep 2014

Quality Assurance Specialist

Contract Pharmacal Corp · Privé

•Tracking and investigation of customer product complaints, analytical failures (OOS/OOT), incidents management, root cause analysis, CAPA, product packaging or shipping non-conformities. Maintenance of QA system consisted of performance tools such Annual Product Review, deviation quality system for manufacturing and packaging processes, and change control systems. •Perform data review, reports and product batch records in support to Quality Review Board meetings (QRB). Provide data analysis reports of quality testing to clients and customers. •Assist with internal audits and GMP operations; provide support for external regulatory audits of the FDA as well as contracting companies by planning, preparing, conducting/executing and responding to deficiencies or observations. •Provide technical support to Regulatory Affairs in submission of Abbreviated New Drug Application (ANDA) to the Federal Drug Administration.
Feb 2012 — Nov 2013

Quality Control Chemist II

Contract Pharmacal Corp · Privé

•Perform testing on Raw Materials and Finished solid dosages such as over the counter (OTC) products, dietary supplements (DS) and controlled drug substances (CDS) as per established specifications, international Pharmacopeias (BP, JP and USP), as well as approved in-house procedures. •Employ wet chemistry and instrumental laboratory techniques (HPLC, UPLC, FTIR, UV-Vis, ICP) in sample preparation and products analysis. •Ensure compliance in testing activities with respect to procedures, FDA regulations, and other regulatory expectations and requirements. •Assist with instrumentation troubleshooting and calibration, documentation, safety and regulatory compliance in accordance with GMPs.
Sep 2009 — Feb 2012

Quality Control Chemist

Fougera Pharmaceuticals Inc · Privé

•Perform analysis on liquids and semi fluids such as creams, ointments, gels and lotions in accordance with approved procedures and specifications. •Provide assistance in the operation and maintenance of laboratory equipment and analytical instrumentation. •Assist the Research and Development lab (R&D) in developing new testing procedures, validation study and stability program. •Provide quality assurance input for troubleshooting, failure analysis and problem solving activities related to the testing of in-process and finished goods, drug substances or products.
Sep 2006 — May 2009

Undergraduate Research Student

Salve Regina University · R&D

•Work on the development of immunosensors-based nanomaterial for a simultaneous early detection of multiple cancer biomarker proteins in clinical relevant samples under the NIH grants program. •Provide regular updates on ongoing biomedical research by preparing quarterly poster presentations for the NIH and ACS members, and other university students throughout the United States.

Compétences

Base de Données
SQL
Systèmes d'Exploitation
Linux Administration Windows Server Administration

Formation académique

2014

Maitrise — Chimie

St. Johns University

2009

Diplôme — Chimie

Salve Regina University

2005

Bac II

Institution Sacre-Coeur De Turgeau

Langues

Créole d’Haïti Langue maternelle
Français Langue maternelle
Anglais Avancé
Espagnol Avancé